Medifast 5 & 1 Plan

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The purpose of this study is to compare the effectiveness of the Medifast 5 & 1 Plan to a food-based, reduced-energy diet plan. The study will be conducted over 52 weeks, including a 26-week weight-loss phase and a 26-week weight-maintenance phase. 120 participants will be enrolled, with 60 randomized to the Medifast 5 & 1 Plan and 60 randomized to food-based, reduced-energy diet plan. Multiple measures will be performed at baseline, 26 weeks, and 52 weeks, including anthropometry, body composition, blood pressure, blood assays, and appetite sensations.

Control participants will be provided with a 1000-kcal/d meal plan based on regular foods selected and procured by participants. Food lists, sample menus, and portion size references will be provided.

Experimental: Medifast 5 & 1 Plan

Other: Medifast 5 & 1 Plan

Participants randomized to the Medifast group will enroll online in the Medifast 5 & 1 Plan. This plan consists of 5 portion-controlled, nutritionally-balanced Medifast Meals plus one Lean & Green Meal each day. Medifast Meals come in individual packets that are mixed with water and microwaved or refrigerated, and are available in a wide variety of foods and flavors. There are >70 Medifast Meal choices, and Medifast Meals may be used interchangeably, so any five Medifast Meals can be chosen for the 5 & 1 Plan. The Medifast 5 & 1 Plan provides approximately 800 to 1,000 kcal/d. The Lean & Green Meal consists of a lean meat plus salad and/or vegetables selected by the participant. Intervention participants will have online access to Medifast dietitians, Medifast trainers, a Medifast message board, and a Medifast chat room, allowing them to interact with others on the Medifast 5 & 1 Plan.

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Ages Eligible for Study:

19 Years to 65 Years (Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

BMI 35-50 kg/m2

Interested in weight loss

Computer with internet access

Any race or ethnicity

Fasting glucose <126 mg/dL at screening

Exclusion Criteria:

Participation in any weight-reduction program, weight-loss diet, or other special diet within the previous 3 months.

History of or current eating disorders, or an Eating Attitudes Test (EAT 40) score >30.

Active food allergies, particularly to wheat, gluten, soy or nuts.

Conditions or behaviors likely to effect the conduct of the trial: unable or unwilling to give informed consent; unable to communicate with the pertinent clinic staff; another household member is a participant or staff member in the trial; unwilling to accept treatment assignment by randomization; current or anticipated participation in another intervention research project that would interfere with the intervention offered in the trial; likely to move away from participating clinics before trial completed; unable to walk 0.25 mile in 10 minutes.

Any active use of illegal or illicit drugs or history of illegal or illicit drug utilization within past year

Excessive alcohol intake, either acute or chronic defined as any one of the following: 1) average consumption of 3 or more alcohol containing beverages daily; 2) consumption of 7 or more alcoholic beverages within a 24-hr period in the past 12 months; or 3) other evidence available to clinic staff.

Willing to limit alcohol intake to zero

Pregnancy and childbearing: currently pregnant or less than 3 months post partum; currently nursing or within 6 weeks of having completed nursing; pregnancy anticipated during study; unwilling to report possible or confirmed pregnancies promptly during the course of the trial; unwilling to take adequate contraceptive measures if potentially fertile.

Any other conditions which, in opinion of the investigators, would adversely affect the conduct of the trial.